|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
7 January 2013 |
|
Main ID: |
NCT00394602 |
|
Date of registration:
|
30/10/2006 |
|
Primary sponsor: |
|
|
Public title:
|
Chemoradiation-Induced Nausea and Emesis: Quality of Life
|
|
Scientific title:
|
Chemoradiation-Induced Nausea and Emesis: A Prospective Study to Assess Patient Preferences and Quality of Life |
|
Date of first enrolment:
|
April 2004 |
|
Target sample size:
|
200 |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT00394602 |
|
Study type:
|
Observational |
|
Study design:
|
Observational Model: Case Control, Time Perspective: Prospective
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Charlotte C. Sun, MD |
|
Address:
|
|
|
Telephone:
|
713-745-4380 |
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
Charlotte C. Sun, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
M.D. Anderson Cancer Center |
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
1. Patients receiving 5 to 6-week course of chemoradiation for abdominal-pelvic tumors
(gastric cancers, gastro-esophageal (GE) junction, pancreatic, cervix, vulvar,
endometrial, or anal) using conventional fractionation [(180cGy-200cGy per day)]
2. Patients receiving concurrent abdominal-pelvic radiation and single agent or
combination of cisplatin, paclitaxel, CPT-11, oxaliplatin or 5-FU, capecitabine,
gemcitabine, or bevacizumab (Avastin).
3. Patients must be least 18 years of age
4. Controls must be individuals with no prior cancer diagnosis
5. Controls must be at least 18 years of age
6. Controls must be the caregivers of patients on this study
Exclusion Criteria:
1. Patients who do not have a diagnosis of cervix, endometrial, vulvar or anal cancer
2. Patients who are not scheduled to receive chemoradiation treatment
3. Patients who are not at least 18 years of age
4. Controls - individuals who have a prior diagnosis of cancer (with the exception of
non-melanoma skin cancer)
5. Controls - individuals who are not at least 18 years of age
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Anal Cancer
|
|
Cervical Cancer
|
|
Endometrial Cancer
|
|
Gastric Cancer
|
|
Pancreatic Cancer
|
|
Vulvar Cancer
|
|
Intervention(s)
|
|
Behavioral: Interview
|
|
Other: Questionnaire
|
|
Primary Outcome(s)
|
|
Longitudinal Quality of Life + Symptom Assessment Data
[Time Frame: Survey(s) & Interveiw(s) at baseline (beginning of chemoradiation treatment), 3 weeks after treatment starts, the last day of treatment, and at the first follow-up appointment after chemoradiation treatment ends.]
|
|
Secondary ID(s)
|
|
2003-0529
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|